A prospective, open label, multicenter clinical trial to assess efficacy and safety of Lipid based Amphotericin B gel 0.1% (Amfy gel®) in patients with moderate to severe vulvovaginal candidiasis after treatment failure with anti-fungal azoles.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Proportion of patients with clinical cure
研究概览
简要总结
Vulvovaginal candidiasis(VVC) is a common problem in women worldwide, with 75 per cent of women experiencingsymptomatic disease at least once throughout their childbearing years.Anti-fungal azoles, including clotrimazole, fluconazole and imidazoleadministered as topical cream, vaginal pessary or oral tablets remain thestandard of care and are effectivein about 70-90% of cases. About 20% ofpatients fail treatment, i.e remain symptomatic and culture positive followinga single standard dose or short course of treatment with anti-fungal azoles.The causes for treatment failure include poor compliance, non-albicansinfection or severe disease.
Amphotericin B is apolyene antifungal drug, often used for systemic fungal infections, produced byStreptomyces nodosus. Amphotericin B associates with ergosterol, the maincomponent of fungal cell membranes, forming a transmembrane channel that leadsto monovalent ion (K+, Na+, H+ and Cl-) leakage, which is the primary effectleading to fungal cell death. It is broad spectrum Antifungal drug and quiteeffective against yeasts (Candida albicans, Candida neoformans), endemicmycoses (Histoplasma capsulatum, Blastomyces dermatitidis and Coccidiodes immitis) and pathogenic molds(Aspergillus fumigatus andMucormycosis).
The Amfy® gel (Lipid BasedAmphotericin B Gel 0.1%) has been approved by the regulatory authorities formarketing in India. As a part of the extended monitoring efforts to monitor thesafety and efficacy of the gel, this post marketing surveillance study is beingconducted in the patients of Vulvovaginal candidiasis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients’ ≥18 years of age, on an acceptable form of birth control throughout treatment period.
- •2.The patient willing to give written, signed and dated informed consent to participate in the study before initiating any study related procedure.
- •3.Clinical diagnosis of symptomatic vulvovaginal candidiasis (score at screening and baseline visit ≥7 – moderately severe cases) confirmed at screening visit by positive KOH wet mount test.
- •4.History of completing a single standard dose or short course of treatment with anti-fungal azoles within three months of the current symptomatic episode of VVC.
- •5.Patient complies with all clinical trial instructions and procedures.
排除标准
- •1.Pregnant or breastfeeding or planning to become pregnant during the treatment period.
- •2.Diagnosed with disseminated candidiasis or requires systemic antifungal therapy.
- •3.Has received any topical/systemic antifungal therapy within 7 days prior to visit 2 (baseline).
- •4.Women suffering from other active infectious cause(s) of vulvovaginitis (e.g., Bacterial vaginosis, Trichomonasvaginalis, Chlamydia trachomatis, Neisseria gonorrhea, symptomatic Herpes Simplex Virus-1 (HSV-1), symptomatic HSV-2, or symptomatic human papilloma virus).
- •5.Women with current use of any immunosuppressive drugs, including systemic or topical vaginal corticosteroids.
- •6.Known case of Hypersensitivity or intolerance (e.g., elevation of liver enzymes) to Amphotericin B.
- •7.Diagnosed with any concomitant condition that, in the opinion of the investigator, could interfere with the evaluation of efficacy or safety, or would make it unlikely that the patient would complete the study.
结局指标
主要结局
Proportion of patients with clinical cure
时间窗: At the end of 14 day course of treatment.
次要结局
- •Any adverse event reported voluntarily, observed or enquired during the safety period(•Proportion of patients with negative KOH wet mount test at the end of 14 day course of treatment.)